Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000595516
Ethics application status
Approved
Date submitted
15/05/2015
Date registered
9/06/2015
Date last updated
9/06/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of implicit versus explicit instruction on a cognitive bias modification task in relation to pain
Scientific title
The effect in healthy participants of implicit versus explicit cognitive bias modification for interpretation on responses to a cold pressor task
Secondary ID [1] 286719 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 295085 0
Condition category
Condition code
Musculoskeletal 295335 295335 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a computerized task. Participants are either trained to interpret ambiguous tasks as painful or happy; and are either trained implicitly or explicitly. So, there are four arms: Arm 1: An implicit task where ambiguous faces are followed by a target that appears where the target was previously replaced by the painful face. Arm 2: An implicit task where ambiguous faces are followed by a target that appears where the target was previously replaced by the happy face. Arm 3: An explicit task where participants are asked to indicate if they consider the ambiguous face to be happy or painful and are given feedback that they are incorrect if they choose happy and correct if they choose painful. and Arm 4:An explicit task where participants are asked to indicate if they consider the ambiguous face to be happy or painful and are given feedback that they are incorrect if they choose painful and correct if they choose happy. Each of the four arms administers a single one-off computerized training that lasts 20-30 minutes and the cold pressor is the outcome not part of the intervention.
Intervention code [1] 291879 0
Other interventions
Comparator / control treatment
The two interventions are compared to each other. One trains people to interpret ambiguous stimuli as painful and the other as happy.
Control group
Active

Outcomes
Primary outcome [1] 295083 0
HesitanceThe amount of time (taken with a stopwatch) between when the participant is asked to place their arm in the cold pressor tank and when they do so.
Timepoint [1] 295083 0
post-treatment
Primary outcome [2] 295084 0
ToleranceThe length of time (stopwatch) that participants are able to tolerate keeping their arm in the cold pressor. Maximum = 4 minutes.
Timepoint [2] 295084 0
During the cold pressor task at post-treatment
Primary outcome [3] 295085 0
Pain Average pain on a numerical rating scale (0-10). Pain ratings taken at threshold and tolerance.
Timepoint [3] 295085 0
During the cold pressor task after treatment
Secondary outcome [1] 314724 0
ThresholdThe amount of time before participants report pain.
Timepoint [1] 314724 0
During the cold pressor task
Secondary outcome [2] 314725 0
Distress: How much distress participants experienced during the cold pressor task on a scale of subjective units of distress 0 -10.
Timepoint [2] 314725 0
post-treatment after completion of the cold pressor task

Eligibility
Key inclusion criteria
First year psychology students
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Raynauld's phenomena, epilepsy, pain disorders, heart conditions.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants volunteer from an online system in exchange for course credit. A schedule of randomized numbers is determined by computer and linked to consecutive participant numbers and concealed until the participant arrives.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomizer.org
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
This is a 2 (implicit vs explicit) x 2 (training towards painful vs happy expressions) design.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will analyse data using a 2 x 2 ANOVA. We will also assess interpretation bias and determine with the use of regression analyses whether implicit or explicit interpretation biases analyses mediate the relationship between group allocation and outcome. Power analyses indicated that we needed a total sample of 104 to achieve 80% power, p = 0.05 given an effect size of 0.28 (achieved in previous studies).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/07/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
104
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 9686 0
2006 - The University Of Sydney

Funding & Sponsors
Funding source category [1] 291278 0
Self funded/Unfunded
Name [1] 291278 0
Nil
Country [1] 291278 0
Primary sponsor type
University
Name
The University of Sydney
Address
School of Psychology
Brennan MacCallum Building A 18
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 289953 0
None
Name [1] 289953 0
Address [1] 289953 0
Country [1] 289953 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292844 0
The University of Sydney
Ethics committee address [1] 292844 0
Jane Foss Russell Building
The University of Sydney
NSW 2006
Ethics committee country [1] 292844 0
Australia
Date submitted for ethics approval [1] 292844 0
Approval date [1] 292844 0
01/05/2015
Ethics approval number [1] 292844 0
2015/182

Summary
Brief summary
This study will investigate the effect of modifying interpretations of ambiguous faces on performance of a painful task. Specifically, we will compare how effective training participants to interpret an ambiguous facial expression as happy compared to painful. We are interested to know whether this training is more effective when instructions are explicit versus implicit.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57306 0
Prof Ann Louise Sharpe
Address 57306 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 57306 0
Australia
Phone 57306 0
61293514558
Fax 57306 0
Email 57306 0
louise.sharpe@sydney.edu.au
Contact person for public queries
Name 57307 0
Louise Sharpe
Address 57307 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 57307 0
Australia
Phone 57307 0
61293514558
Fax 57307 0
Email 57307 0
louise.sharpe@sydney.edu.au
Contact person for scientific queries
Name 57308 0
Matteo Zuccala
Address 57308 0
Brennan MacCallum Building A18
The University of Sydney
NSW 2006
Country 57308 0
Australia
Phone 57308 0
612401262198
Fax 57308 0
Email 57308 0
mzuc6712@uni.sydney.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.